Replies to post #667421 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Gus, NWBO would not be allowed to market off label.

Many do not understand what "market" means. NWBO would not be allowed to manufacturer -L based on non approved tumor cells and sell it commercially under the approved label.

There is some off label use that could and would happen. But they will be limited to the fringe cases. Non GBM brain tumors. Patients who have low WBCs. Patients who cannot get off steroids, patients with previous use of XYZ, patients with other health issues and similar stuff.

OTOH, If a doc sent in a a lung cancer sample to have -L produced commercially it would absolutely be illegal for NWBO to manufacture and sell it.

OK, this is US law. I am 99.999% certain UK law is the same though.

[Smitty5150]

they can probably off-label, yes. But there are ramifications if something happens such as a ASE...both for the reputation's of NW and the Doctor that Rx'ed it. I suspect NW and Advent will not want to allow off-labeling for this reason. We are not talking about a small-molecule here...we are talking about a expensive personized vaccine. Sure there are forms a patient could sign to take responsibility, but a good lawyer can find loop-holes in anything. The real damage would be winding up on the front line story of some news channel at 5pm and the reputation of a new drug goes down to the tubes because you off-labeled it to a cancer indication it was not tested in. I suspect it wont happen because of these issues. But as more trails are run, and data is known, you may see it. But we are a few years away from that.